Evaluation and Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients Entering Intensive Care Units for Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 780
- 试验地点
- 7
- 主要终点
- Negative predictive value of the studied prognostic score
研究概览
简要总结
A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.
The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.
详细描述
There are two secondary objectives:
- Validate a prognostic score for death at the end of the first week from initial data.
- Validate a predictive score of disseminated intravascular coagulation (DIC) in patients with septic shock by comparing with the Gold Standard of the International Society on Thrombosis and Haemostasis (overt-DIC in the first 5 days after inclusion).
As for the main objective, these scores are based on biological markers scored under emergency situations within the first 24 hours of routine clinical practice management for septic shock.
The objectives and endpoints stated correspond to the protocol directly submitted to ethics authorities prior to the first inclusion and can be verified by contacting the Committee for the Protection of Persons Sud Mediterranée III (mail: CPP SUD-MEDITERRANEE III, UFR MEDECINE 186, chemin du Carreau de Lanes CS 83021, 30908 NIMES Cedex 2 FRANCE. Study reference: 2008.11.04 bis) For more information: carey.suehs@chu-nimes.fr
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient (or representative) received the information notice
- •patient has hemodynamic insufficiency of non-traumatic or cardiogenic origin associated with severe sepsis (treated with Noradrenalin) and organ dysfunction, hypoperfusion or hypotension
- •body temperature > 38.3°C or < 36°C
- •heart rate > 90 bpm
- •Tachypnea > 20 C/min or PaCO2 < 32 mmHg or mechanical ventilation
- •leukocytes > 12000 µL-1 ou < 4000 µL-1 ou > 10% immature forms
- •oliguria < 0.5 ml/kg/h for at least 2 hours
- •abrupt alteration (24 h) of conscienceness
- •thrombocytopenia < 100 000 G/L or disseminated intravascular coagulation
- •mottled skin and / or capillary refill time> 3 sec
- •PaO2/FiO2 < 300 mmHg ou < 40KPas
- •Lactatemia > 2mMol/l
- •septic shock: Systolic Blood Pressure (SBP) > 90 mmHg or need for vasopressors to maintain SBP> 90 mmHg despite a prior filling (20-30 ml / kg of macromolecules or 40 to 60 ml / kg of normal saline (or decrease in SBP> 40% in the hypertensive)
排除标准
- •patient is dying or limitation or cessation of active treatment
- •patient is already included in another trial
- •patient or family refusal
- •patient not affiliated with a social security system
研究组 & 干预措施
Septic shock patients
干预措施: Routine biological analyses (Biological)
结局指标
主要结局
Negative predictive value of the studied prognostic score
时间窗: 24 hours (studied score parameters); 1 month (mortality)
The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death. The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
AUC of the studied prognostic score
时间窗: 24 hours (studied score parameters); 1 month (mortality)
The biological parameters measured at the time of admission to the intensive care unit and that make up the prognostic score for death at 1 month will be collected. The event "death within 1 month" will be analyzed. For patients discharged from service before the end of the first month, the clinician will still be informed concerning possible death. The studied biological parameters correspond to routine coagulation and hematological parameters for patients in septic shock, according to SFAR (Société Française d'Anesthésie et de Réanimation) recommendations and the SRLF (Société de Réanimation de Langue Française) Consensus (2002).
次要结局
- Negative predictive value for the studied prognostic score(24 hours (studied score parameters); 5 days (DIC))
- AUC of the studied prognostic score(24 hours (studied score parameters); 5 days (DIC))
- Negative predictive value of the studied prognostic score(24 hours (studied score parameters); 1 week (mortality))